Director CMC

7 days ago

Hatfield, Hertfordshire, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly experienced Director, CMC to join our team at Pharmiweb. As a key member of our regulatory affairs department, you will be responsible for ensuring the quality and accuracy of our biologics products' regulatory submissions.

Key Responsibilities
  • Manage and prepare CMC sections of regulatory submissions, including EU IMPD/MAA and rest of world equivalent documents.
  • Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior management, and ensure on-time delivery of high-quality submission documents.
Requirements
  • Demonstrated experience with preparation of major biologics submissions, multiple IMPD submissions, and MAA submissions.
  • Demonstrated experience with biochemistry, especially antibody and immune system biological processes.
  • Advanced degree preferred.
What We Offer
  • Competitive salary and excellent benefits package.
  • Hybrid working arrangement.
  • Discretionary bonus.
  • Free onsite parking.
  • Subsidized onsite restaurant and coffee shop.
  • Learning and development opportunities.
  • Retail discounts.
  • Well-being and mental health awareness programs.
About Us

Pharmiweb is a leading research-based pharmaceutical organization with an extensive portfolio across various therapy areas. We are committed to putting the patient first in everything we do.

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